Recall Z-1239-2012
Beckman Coulter Inc. · initiated November 10, 2011
Product
Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Codes / lots: Lot Numbers: Expiration dates: 009091 10/10/2010 109636 09/30/2011 013491 10/31/2010 113465 10/31/2011 013492 11/30/2010 113969 10/31/2011 014488 12/31/2010 114261 11/30/2011 015211 02/28/2011 115485 12/31/2011 018855 03/31/2011 116660 01/31/2012 020420 04/30/2011 118211 02/28/2012 021285 05/31/2011
Reason for recall
The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
FDA-determined cause: Process design
Action taken
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.
Details
- Recall number
- Z-1239-2012
- Initiated
- November 10, 2011
- Posted by FDA
- March 21, 2012
- Terminated
- June 26, 2012
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 4961 units total (1321 units in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1238-2012 | Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | 11/10/2011Terminated |
| Z-1240-2012 | Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | 11/10/2011Terminated |